FDA Enters Withdrawal: Agency Must Pursue Limits on Penicillins and Tetracyclines

Yesterday, a federal magistrate ordered the Food and Drug Administration (FDA) to move ahead with a decades-old effort to withdraw approvals for several uses of antibiotics considered “critically important” to human health by the World Health Organization.  This is a solid win for public health advocates and comes as FDA has proven unwilling to take seriously the threat of antibiotic resistance.

In 1977, FDA proposed withdrawing approvals for the use of penicillin antibiotics for growth promotion and the use of several tetracycline antibiotics in animal feed.  Research showed then—more than three decades ago—that these uses were likely to select for antibiotic-resistant bacteria that can infect humans.  Unfortunately, lobbyists for the pharmaceutical and animal agricultural industries persuaded Congress to delay the restrictions pending additional research.  FDA did more research but took no further action for the next 34 years. Read More >

One Step Forward, Two Steps Back: FDA on Cephalosporin, Penicillin, and Tetracycline

Last Tuesday, the U.S. Food and Drug Administration (FDA) announced that it will ban the “extra-label” use of cephalosporin antibiotics in food animals—that is, veterinarians will not be permitted to use drugs in this class of antibiotics except in ways approved by FDA.  (A “drug class” refers to a group of drugs that work in similar ways.  Cephalosporins are members of the broad group of beta-lactam antibiotics, which includes penicillin drugs as well.  Beta-lactams kill bacteria in similar ways.) FDA’s announcement came almost two weeks after the agency said it would not restrict the use of the other group of beta-lactams, penicillins, as well as tetracyclines, two other drug classes on which it had contemplated taking action. In the span of just two weeks, then, FDA has moved to prevent misuse of one drug while shirking its responsibility for two others. One step forward, two steps back. Read More >